Development Stage: In vitro and retrospective in vivo with each of 8 biomarkers evaluated in up to 100 human tissues: a combination of normal, benign and cancer tissues

Novelty: New class of cancer biomarkers that allow quantitative analysis of tissue sample rather than qualitative. Requires a very small tissue sample (150-200 cells) and no prior knowledge of tumor makeup

Clinical Application: Could be used as a first-line diagnostic tool, potentially as a replacement for or adjunct to traditional histological diagnosis procedures. Could be used in combination with established diagnostic method to achieve increased accuracy

Development Stage: Preclinical in mice, tested both pre- and post-immunization with viable tumor cells from four different cancer cell lines

Novelty: Personalized medicine with immune system stimulators conjugated to apoptotic tumor cells specific to the individual undergoing treatment. Therapy can be generated from a biopsy sample as it only requires a small amount of cells to create therapy

Clinical Application: Could be administered to tumor-presenting patients to reduce tumor size, to prevent recurrence and metastasis following surgical resection of tumors, or to prevent tumor development in patients at risk of developing certain types of cancer

How it works: A platform for new bioactive breast tissue lumpectomy and mastectomy reconstructive options targeting cancer recurrence prevention

Patent status: Patent granted (#6,991,652) for a biocompatible composite for use in a living subject, comprising a material selected from the group consisting of alginate, collagen, polylactide, polyethylene glycol, polycaprolactone, polydioxanone, and derivatives, and copolymers thereof and having a diameter of about 1.5 mm or less distributed within a carrier. No patent for Tannic acid (TA)-collagen per se, however issued patent anticipates the incorporation of active agents i.e. Tannic Acid. Patent also granted (# 8,293,531) for a benchtop diagnostic system for testing therapies, devices, vaccines.

Clinical Application: Could be used as a novel method of recurrence prevention for ER-positive breast cancer after mastectomy. Could be used in a benchtop diagnostic to personalize treatment by identifying cancer cell types within a tumor.

Novelty: Fully human monoclonal antibody which targets a different region of mesothelin than the current clinical candidates

Clinical Application: As a cancer therapeutic either alone or in combination. Potential use in antibody-drug conjugates or in vaccines. Potential use in generation of a diagnostic kit for mesothelin-expressing cancers

*Special Note: For this invention, breast cancer is the only field of use available for the start-up phase of the challenge. Teams may use the background data associated with this invention related to other cancers in order to fully understand the toxicology, efficacy, and other scientific parameters as well as to understand how the commercialization, development and regulatory landscape may evolve based on the invention as a whole

How it works: Monocytes are isolated from individual patients and treated with a 15 kD granulysin, a molecule that induces the formation of dendritic cells which are injected back into the patient to stimulate the immune system

Novelty: Less toxic and more target specificity than current delivery methods; eliminates the need for expensive antigen purification methods

Clinical Application: Delivery of proteins or miRNA or coding RNA into cells, direct antibody production by in vivo injection of replicons, in vivo cancer treatment by converting cancer cells into antigen presenting cells.

Novelty: Only six genes are used to diagnose and predict the reoccurrence of breast cancer versus 16 to 70 genes. Broadly applicable as the test is not specific to a certain type of breast cancer. The six gene model is also applicable to lung cancer and was tested in six lung cancer data sets. May also be applicable in other cancers

Clinical Application: Can be used when patients have been diagnosed with cancer to predict disease progression and, therefore, guide treatment decisions. A future application could also be to identify new therapeutics for breast cancer. Since it works in breast and lung cancer, the test has potential to work in other tumor types as well

Development Stage: The biomarkers have been evaluated in 221 patients with extrahepatic cholangiocarcinoma (EHCC), in 220 lung cancer patients, in 946 patients with gastric cancer, as well as in cervical and kidney cancers.

Novelty: Novel biomarkers that predict patient survival

Clinical Application: Prognostic / predictive biomarkers for survival and prediction of response to targeted therapies. Identification of patients who may benefit from mTOR analog-based chemotherapy or agents directed against Akt

Development Stage: The biomarker was evaluated in 1581 primary tumor tissue samples from node-positive operable breast cancer patients who participated in a randomized clinical trial

Novelty: AKT phosphorylation at Ser473 (pAKT) has been identified as a biomarker that predicts treatment benefit from sequential addition of a taxane (paclitaxel or docetaxel) to doxorubicin and cyclophasphomide (AC) chemotherapy to assist physicians in making treatment decisions for high-risk and node-positive breast cancer patients

Clinical Application: Identification of patients by examining pAKT expression status in pre-treatment surgical tumor specimens or tumor biopsies to receive a taxane if patients have pAKT-positive tumors or spare a taxane if patients have pAKT-negative tumors